RecruitingNot ApplicableNCT07158034

Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation

Sponsor

University of Minnesota

Enrollment

24 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

Tinnitus

Summary

The aim of the proposed study is to investigate the use of resting-state Electroencephalogram (EEG)-Based Brain Entropy (EBDBE) and auditory brainstem responses (ABR) as an objective measure of tinnitus improvement following the use of a bimodal stimulation device in individuals with tinnitus after six weeks of bi-modal stimulation.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

years and over at time of consent
Ability to read and understand English
Willing and able to provide and understand informed consent
Willing to commit to the full duration of the investigation
Subjective tinnitus
Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent (only for participants in treatment group)
Baseline THI score from 40 to 76 (only for participants in treatment group)
Hearing loss condition - can hear the acoustic stimulation of the Lenire device (only for participants in treatment group)
years and over at time of consent
Ability to read and understand English
Willing and able to provide and understand informed consent
Willing to commit to the full duration of the investigation

Exclusion Criteria34

Subjective tinnitus, where pulsatility is the dominant feature (only for participants in treatment group)
Objective tinnitus
Can't hear acoustic stimulation of the Lenire device within its mid- range volume setting
Began wearing hearing aids within the past 3 months
A healthcare provider has diagnosed Meniere's disease or another disorder associated with fluctuating hearing loss.
History of auditory hallucinations
Tumor on the hearing or balance nervous systems
Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
Participant with a pacemaker or other electro-active implanted device
Participant previously diagnosed with psychosis or schizophrenia
Participants diagnosed with Burning Mouth Syndrome
A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
Inability to physically or comprehensively use the device
Oral piercings that cannot or will not be removed
Pregnancy per patient report
Prisoner
PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Began wearing hearing aids within the past 3 months
Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics.
Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
Participant previously diagnosed with psychosis or schizophrenia
A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
Prisoner
PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.

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Interventions

DEVICELenire Device

The Lenire device is a non-invasive stimulation system designed to reduce the symptoms of chronic subjective tinnitus. It includes a controller that is connected to headphones for sound delivery to the ears and a mouthpiece that provides mild electrical stimulation to the surface of the tongue. Users are recommended to use the device for 60 minutes daily, either in two consecutive 30-minute sessions or at different times throughout the day, for a minimum of 36 hours.